SMARTSET GMV 40G US EO

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: E3 INITIAL REPORTER OCCUPATION: LAWYER. "DMF# - (B)(4). TRADE NAME ¿ GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S) ¿ GENTAMICIN SULPHATE, DOSAGE FORM - POWDER, STRENGTH ¿ 1.0G ACTIVE IN OUR CEMENTS." IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD ON (B)(6) 2016. THE PATELLA WAS RESURFACED AND DEPUY SMARTSET CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2024 THE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED HETEROTOPIC OSSIFICATION AND SYNOVITIS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT AND PATELLA WERE RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2024, RIGHT KNEE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. ACCORDING TO THE INFORMATION RECEIVED, "DOI: (B)(6) 2016: FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY SMARTSET CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PRIMARY PART/LOT INFO AVAILABLE ON PP. 5 OF ATTACHED MEDICAL RECORDS. DOR: (B)(6) 2024: 62-YEAR-OLD FEMALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT THE SURGEON IDENTIFIED AND DEBRIDED HETEROTOPIC OSSIFICATION AND SYNOVITIS. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT AND PATELLA WERE RETAINED. THE PATIENT RECEIVED AN ATTUNE REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2024, RIGHT KNEE¿. PRODUCT DESCRIPTION: SMARTSET GMV GENTAMICIN BONE CEMENT, 40G PRODUCT CODE: 545050501 LOT NUMBER: 8068953 QUANTITY OF MANUFACTURED: (B)(4) MANUFACTURING DATE: 05/11/2015 EXPIRY DATE: 04/30/2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: SMARTSET GMV GENTAMICIN BONE CEMENT, 40G PRODUCT CODE: 545050501 LOT NUMBER: 8068953 AND ONE NON-CONFORMANCES WAS IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT 1) QUANTITY MANUFACTURED: (B)(4) 2) DATE OF MANUFACTURE: 05/11/2015 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 04/30/2017 DEVICE HISTORY BATCH NULL. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT DESCRIPTION: SMARTSET GMV GENTAMICIN BONE CEMENT, 40G PRODUCT CODE: 545050501 LOT NUMBER: 8068953 AND ONE NON-CONFORMANCES WAS IDENTIFIED, HOWEVER NOT RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. ADDED: D10 CONCOMITANT CORRECTED: D3, G1, H4.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5. B7, H6 (CLINICAL CODE). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED STATING: PREOPERATIVE CLINIC NOTE DATED 21 NOV 2024: PATIENT REFERRED FOR REVISION TO TREAT PAIN, WALKING DIFFICULTY, DECREASED ROM, JOINT INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL TRAY.